The State Food and Drug Administration (SFDA) formulated and issued Good Manufacturing Practice for Drug Excipients after wide consultation, aiming to strengthen the quality control of the manufacturing of drug excipients and ensure drug excipient quality. Good Manufacturing Practice for Drug Excipients comprises eleven chapters:
ChapterⅠ General Provisions
ChapterⅡ Organization, Personnel and Responsibility
ChapterⅢ Buildings and Facilities
ChapterⅣ Equipment
ChapterⅤ Materials
ChapterⅥ Sanitation
ChapterⅦ Validation
ChapterⅧ Documentation
ChapterⅨ Production Control
ChapterⅩ Quality Assurance and Quality Control
ChapterⅪ Distribution
ChapterⅫ Self-Inspection and Improvement
ChapterⅩⅢ Supplementary Provisions